FDAFDA · Food and drugs·Recall number Z-1274-2014
Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
Published April 2, 2014 · Recall initiated: January 7, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the Drill Template.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.
- Lot
- Part Nos. 03.111.900 through 03.111.905, with Lot Nos. 779372, 2638601, 7769386, 2638603, 7836420, 7772531, 2638604, 7836422, 7772538, 2638605, 7836423, 7915554, 7772543, 7772542, 7872775, 8400287, 7772554, 7772555, and 8229040.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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